Label: EUTHASOL- pentobarbital sodium and phenytoin sodium solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated April 21, 2011

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  • SPL UNCLASSIFIED SECTION

    PRODUCT INFORMATION

    CIII

    FOR DOGS ONLY

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  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • DESCRIPTION

    A non-sterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluish-red fluorescent dye, is included in the formulation to help distinguish it from parenteral drugs intended for therapeutic use. Although the solution is not sterile, benzyl alcohol, a bacteriostat, is included to retard the growth of microorganisms.

    Each mL contains: active ingredients: 390 mg pentobarbital sodium (barbituric acid derivative), 50 mg phenytoin sodium; inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

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  • ACTIONS

    EUTHASOL (pentobarbital sodium and phenytoin sodium) contains two active ingredients which are chemically compatible but pharmacologically different. Each ingredient acts in such a manner so as to cause humane, painless, and rapid euthanasia. Euthanasia is due to cerebral death in conjunction with respiratory arrest and circulatory collapse. Cerebral death occurs prior to cessation of cardiac activity.

    When administered intravenously, pentobarbital sodium produces rapid anesthetic action. There is a smooth and rapid onset of unconsciousness. At the lethal dose, there is depression of vital medullary respiratory and vasomotor centers.

    When administered intravenously, phenytoin sodium produces toxic signs of cardiovascular collapse and/or central nervous system depression. Hypotension occurs when the drug is administered rapidly.

    Pharmacodynamic Activity

    The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of EUTHASOL is similar to that following intravenous injection of pentobarbital sodium, or other barbituric acid derivatives. Within seconds, unconsciousness is induced with simultaneous collapse of the dog. This stage rapidly progresses to deep anesthesia with concomitant reduction in the blood pressure. A few seconds later, breathing stops, due to depression of the medullary respiratory center; encephalographic activity becomes isoelectric, indicating cerebral death; and then cardiac activity ceases.

    Phenytoin sodium exerts its effect during the deep anesthesia stage caused by the pentobarbital sodium. This ingredient, due to its cardiotoxic properties, hastens the stoppage of electrical activity in the heart.

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  • INDICATIONS

    For use in dogs for humane, painless, and rapid euthanasia.

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  • WARNING

    For canine euthanasia only. Must not be used for therapeutic purposes. Do not use in animals intended for food.

    ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

    CAUTION

    Caution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of reach of children. If eye contact, flush with water and seek medical advice/attention.

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  • PRECAUTIONS

    Euthanasia may sometimes be delayed in dogs with severe cardiac or circulatory deficiencies. This may be explained by the impaired movement of the drug to its site of action. An occasional dog may elicit reflex responses manifested by motor movement; however, an unconscious animal does not experience pain, because the cerebral cortex is not functioning.

    When restraint may cause the dog pain, injury, or anxiety, or danger to the person making the injection, prior use of tranquilizing or immobilizing drugs may be necessary.

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  • DOSAGE AND ADMINISTRATION

    Dosage

    Dogs, 1 mL for each 10 pounds of body weight.

    Administration

    Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog, or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection.

    The calculated dose should be given in a single bolus injection.

    For intravenous injection, a needle of sufficient gauge to insure intravenous placement of the entire dose should be used.

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  • HOW SUPPLIED

    EUTHASOL is available in 100 mL multiple dose vials.

    STORAGE

    Store between 15° and 30°C (59° and 86°F).

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  • SPL UNCLASSIFIED SECTION

    Manufactured for Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161

    For Technical Service contact (800) 338-3659.

    © 2003 Virbac AH, Inc. EUTHASOL is a registered trademark of Virbac AH, Inc.

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  • SPL UNCLASSIFIED SECTION

    ANADA #200-071, Approved by FDA
    02234

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  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    NDC-051311-050-01

    Virbac
    ANIMAL HEALTH

    Euthasol®
    (Euthanasia Solution)

    For Dogs Only

    Caution: Federal law
    restricts this drug to use
    by or on the order of a
    licensed veterinarian.

    ANADA # 200-071,
    Approved by FDA

    100 mL

    CIII

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    EUTHASOL 
    pentobarbital sodium and phenytoin sodium solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-050
    Route of Administration INTRAVENOUS DEA Schedule CIII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pentobarbital sodium (UNII: NJJ0475N0S) (pentobarbital - UNII:I4744080IR) pentobarbital sodium 390 mg  in 1 mL
    phenytoin sodium (UNII: 4182431BJH) (phenytoin - UNII:6158TKW0C5) phenytoin sodium 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    alcohol (UNII: 3K9958V90M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    rhodamine B (UNII: K7G5SCF8IL)  
    benzyl alcohol (UNII: LKG8494WBH)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    Product Characteristics
    Color RED (bluish-red) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51311-050-01 100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200071 05/05/2004
    Labeler - Virbac AH, Inc. (131568396)
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